H.P. Acthar® Gel in Dermatomyositis and Polymyositis Treatment Registry: An Interim Analysis

Levine, Todd; Malone, Justin; Efthimiou, Petros; T, Rup; Dikranian, Ara; Levine, Aidan; Saperstein, David

doi:10.4172/2329-6895.1000292

Cited by 10 publications

(8 citation statements)

References 22 publications

(31 reference statements)

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“…An interim analysis of the Acthar in Dermatomyositis and Polymyositis Treatment (ADAPT) registry reported responses to RCI treatment in 14 (58%) of 24 enrolled patients with refractory DM/PM. 20 Most of the patients (92%) received RCI 80 U twice weekly, and the mean duration of RCI treatment was 9.7±4.0 months for responders and 3.5±1.4 months for nonresponders. Ten (42%) patients had mild-to-moderate AEs, including worsening of diabetes (12%) and lower extremity edema (8%), which were the only AEs experienced by >1 patient.…”

Section: Safetymentioning

confidence: 96%

“…18 Given that DM/PM is a rare disease, it is not surprising that there are a small number of published reports with results on the clinical efficacy and safety of RCI in patients with refractory DM/ PM. [19][20][21] RCI is not a common medication used for inflammatory conditions. In clinical settings, it is often used after other therapies have failed.…”

Section: Introductionmentioning

confidence: 99%

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<p>Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis</p>

Mahler¹,

Turner²,

Eaddy³

et al. 2020

OARRR

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Purpose: Repository corticotropin injection (RCI) is indicated for a number of autoimmunemediated diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and dermatomyositis (DM)/polymyositis (PM). To better understand the practice patterns and outcomes of RCI in patients with RA, SLE, or DM/PM, we conducted a retrospective medical record analysis. Patients and Methods: Participating providers selected deidentified medical records of patients meeting the inclusion criteria (age ≥18 years; physician-reported diagnosis of RA, SLE, or DM/PM; initiation of treatment with RCI between 1/1/2011 and 2/15/2016; ≥3 inoffice visits with same site/provider). Collected data spanned 12 months before and after the first prescription date for RCI. Analyses included patient demographics and clinical history, RCI treatment patterns, and physician's impression of change. Results: Data from 54 patients with RA, 30 patients with SLE, and 8 patients with DM/ PM were analyzed. The most frequently reported reasons for initiating RCI were lack of efficacy with prior treatment, acute exacerbation of disease, and use as add-on to ongoing therapy. The most common initial RCI dosing, 80 U twice weekly, was used for 84% of patients with RA, 75% with SLE, and 86% with DM/PM. The mean duration of treatment was 4.8, 6.5, and 6.8 months for RA, SLE, and DM/PM, respectively. Among the 57 patients with data on physician's impression of change with RCI, 78.1% of patients with RA, 94.7% with SLE, and 66.7% with DM/PM had a rating of "improved," and the mean time to best impression of change was 3.4, 4.3, and 3.4 months for RA, SLE, and DM/PM, respectively. Conclusion: This study reports the real-world patient profile, use patterns, and outcomes of patients who used RCI for the treatment of RA, SLE, and DM/PM. These data can inform appropriate use and clinical expectations when using RCI.

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Section: Safetymentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

<p>Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis</p>

Mahler¹,

Turner²,

Eaddy³

et al. 2020

OARRR

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“…Acthar ® Gel; Mallinckrodt Pharmaceuticals, Hazelwood, MO, USA) 7. Previous studies have shown RCI to be tolerated and effective in treating DM/PM in a limited number of patients 17,18…”

Section: Introductionmentioning

confidence: 99%

Medical resource utilization in dermatomyositis/polymyositis patients treated with repository corticotropin injection, intravenous immunoglobulin, and/or rituximab

Knight¹,

Bond²,

Popelar³

et al. 2017

CEOR

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BackgroundDermatomyositis and polymyositis (DM/PM) are rare, incurable inflammatory diseases that cause progressive muscle weakness and can be associated with increased medical resource use (MRU). When corticosteroid treatment is unsuccessful, patients may receive intravenous immunoglobulin (IVIg), rituximab, or repository corticotropin injection (RCI). This study compared real-world, non-medication MRU between patients treated with RCI and those treated with IVIg and/or rituximab for DM/PM.MethodsClaims of DM/PM patients were analyzed from the combination of three commercial health insurance databases in the United States from July 2009 to June 2014. Patients treated with RCI were propensity score matched to those treated with IVIg, rituximab, and both (IVIg+rituximab) based on demographics, prior clinical characteristics, and prior MRU. Per-patient per-month (PPPM) MRU and costs were compared using Poisson regression and generalized linear modeling, respectively.ResultsOne-hundred thirty-two RCI, 1,150 IVIg, and 562 rituximab patients had an average age of 52.6, 46.6, and 51.7 years, respectively, and roughly two-thirds were female. After matching, there were no significant differences in demographics or prior clinical characteristics. RCI patients had fewer PPPM hospitalizations (0.09 vs 0.17; P=0.049), shorter length of stay (LOS; 3.24 days vs 4.55 days; P=0.004), PPPM hospital outpatient department (HOPD) visits (0.60 vs 1.39; P<0.001), and PPPM physician office visits (2.01 vs 2.33; P=0.035) than IVIg. RCI had fewer PPPM HOPD visits (0.56 vs 0.92; P<0.001) than rituximab. Patients treated with RCI had shorter LOS (2.18 days vs 5.15; P<0.001) and less PPPM HOPD visits (0.53 vs 1.26; P<0.001) than IVIg+rituximab. Total non-medication PPPM costs were 23%–75% lower for RCI compared to IVIg ($2,126 vs $3,964; P<0.001), rituximab ($2,008 vs $2,607; P=0.018), and IVIg+rituximab ($1,234 vs $4,858; P<0.001).ConclusionPatients treated with RCI had less PPPM non-medication MRU and costs than those treated with IVIg and/or rituximab, particularly in the hospital setting where significant costs are incurred.

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“…The primary outcome measure was to look at the safety profile and efficacy of RCI in refractory adult PM/DM patients for at least a year post-treatment. The secondary outcome measures are to see the response in all the subgroups/types of myositis patients with an intent to identify if a particular subgroup of patients responded better to RCI therapy than others [45, 46].…”

Section: Emerging Therapiesmentioning

confidence: 99%

Biologics in refractory myositis: experience in juvenile vs. adult myositis; part II: emerging biologic and other therapies on the horizon

Patwardhan

Spencer

2019

Pediatr Rheumatol

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The idiopathic inflammatory myopathies (IIM) until recently have been considered a heterogeneous broad group of six autoimmune muscle diseases. Initially, autoantibodies in IIM (including JDM) and CD8+ T cell-induced cytotoxicity (PM and IBM) were the predominant recognized etiopathology mechanisms used to classify myopathies. In the early late 1990’s to 2000’s, evolving understanding of the molecules such as interleukin (IL), tumor necrosis factor (TNF), interferon (IFN), and other cytokines as well as differences in response to therapies, has led IIM researchers to look beyond previous disease mechanisms. For decades the overexpression of Th1- associated cytokines (TNF-α, IFN-γ and IL-12) in the areas of inflammation in skin and muscle in IIM pointed to Th1 as the primary pathway for inflammation in myositis. However, in the last decade overexpression and elevated level of Th17-associated cytokines (IL-17, IL-22, and IL-6) were identified in the blood and the inflamed muscles of myositis patients. We also do not know how Th1 and Th2 cytokines work differently in diverse hosts, in different concentrations, in different inflammatory milieus, and in the presence or absence of each other or other adhesion/co-stimulatory molecules such as NF-κB. Also, several autoantibodies to intracellular organelles have been identified in myositis. In this review, we will discuss the most recent advances in IIM research and how that might bring new biologic therapies to market in the next 5–15 years to assist in the care of our most difficult IIM and JDM patients.

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H.P. Acthar® Gel in Dermatomyositis and Polymyositis Treatment Registry: An Interim Analysis

Cited by 10 publications

References 22 publications

<p>Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis</p>

<p>Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis</p>

Medical resource utilization in dermatomyositis/polymyositis patients treated with repository corticotropin injection, intravenous immunoglobulin, and/or rituximab

Biologics in refractory myositis: experience in juvenile vs. adult myositis; part II: emerging biologic and other therapies on the horizon

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